(1) To investigate the efficacy of LT in patients with T2DM and comorbid depression, and (2) whether LT leads to improved insulin sensitivity, and (3) whether effects on mood and metabolic control are mediated by restoration of the circadian…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
o Mean change in IDS-SR scores in the active versus placebo condition (T0-T4).
Secondary outcome
Depression
o Mean change in depressive symptoms (IDS-SR) in the active versus placebo
condition (T0-T8).
o Depression (sustained) remission rates in the active versus placebo condition
(remission is a priori defined as a score of 13 or less (IDS-SR) at T4;
sustained remission is a priori defined as a score of 13 or less (IDS-SR) at T4
and T8).
o Temporal changes in depressive symptoms (IDS-SR) in the active versus placebo
condition (T0,T1, T2, T3, T4, T8).
Diabetes
o Mean change HEC-derived M-value, as measure of whole-body insulin sensitivity
in the active versus placebo condition (T0-T4).
o Mean change in HbA1c in the active versus placebo condition (T0-T4, T0-T8).
o Mean change in fasting plasma glucose in the active versus placebo condition
(T0-T4, T0-T8).
o Mean change in self-reported glucose measures and insulin dosages (if
applicable) in the active versus placebo condition (T0-T4, T0-T8).
Anxiety, emotional functioning in diabetes, quality of life, and disability
o Mean change in anxiety symptoms in the active versus placebo condition
(T0-T4, T0-T8).
o Temporal changes in anxiety symptoms in the active versus placebo condition
(T0-T4, T0-T8).
o Mean change in emotional functioning in diabetes in the active versus placebo
condition (T0-T4, T0-T8).
o Mean change in quality of life in the active versus placebo condition (T0-T4,
T0-T8).
o Mean change in disability in the active versus placebo condition (T0-T4,
T0-T8)
Primary mediators
o Mean change in diurnal cortisol variability in the active versus placebo
condition (T0-T4, T0-T8).
o Mean change in objective actigraphic measures of sleep duration and circadian
rhythmicity in the active versus placebo condition (T0-T4, T0-T8).
o Mean change in subjective measures of sleep duration and quality and
circadian rhythmicity in the active versus placebo condition (T0-T4, T0-T8).
Secondary mediators
o Mean change in the ANS-balance in the active versus placebo condition
(subgroup) (T0-T4, T0-T8).
o Mean change in body mass and composition measures in the active versus
placebo condition (T0-T4, T0-T8).
o Mean change in blood pressure in active versus placebo condition (T0-T4,
T0-T8).
o Mean change in objective actigraphic measures of physical activity and energy
expenditure in the active versus placebo condition (T0-T4, T0-T8).
Safety and tolerability
o Mean change in side-effects in the active versus placebo condition (T0-T4,
T0-T8).
o Temporal changes in side-effects in the active versus placebo condition (T0,
T1, T2, T3, T4, T8).
o Mean changes in ophthalmological measures (fundoscopy, visual acuity, and
contrast sensitivity (subgroup)) (T-3-T8).
Background summary
Depression is common in patients with type 2 diabetes mellitus (T2DM), leading
to increased morbidity and mortality risks. Both depression and T2DM are
associated with a dysfunction of the biological clock, which is implicated in
both diurnal glucose homeostasis and the regulation of the stress-response.
Light Therapy (LT) is an effective, patient friendly, non-pharmacological
antidepressant that stimulates the biological clock. We hypothesize that LT
will improve depressive symptoms and insulin sensitivity, possibly by resetting
the biological clock.
Study objective
(1) To investigate the efficacy of LT in patients with T2DM and comorbid
depression, and
(2) whether LT leads to improved insulin sensitivity, and
(3) whether effects on mood and metabolic control are mediated by restoration
of the circadian rhythmicity.
Study design
A randomized double-blind placebo-controlled clinical trial, consisting of a
2-week run-in period to allow for study effects (T-2-T0), a 4-week intervention
period (T0-T4), and a 4-week follow-up (T4-T8), to assess direct and more
chronic effects of LT.
Intervention
Partcipants will be randomly assigned to the experimental or control condition:
4 week exposure to bright white-yellowish light, 10.000Lux, 0.5 hour every
morning, or 4 week exposure to dim green light, 500 Lux, 0.5 hour every morning
at their homes. Participants choose a 4-week-lasting fixed starting time
anchored within 1 hour from their habitual wake-up time. During therapy, they
sit in front of the boxes on a distance of 50 cm, and can have breakfast or do
some reading (Protocol as recommended by Wirz-Justice, 2009). All lamps will be
equipped with UV-A and UV-B filters, and will contain relatively less
blue-light. We chose to use dim green light as a placebo, reasoning that
because the geen part of the spectrum is biologically relatively inactive,
there would be no substantial effect, although green light may induce positive
expectations, as was proven for dim red light (Loving, 2005). Particicpants
will be informed that the primary goal of the study is to investigate
spectrum-dependent efficacy differences.
Study burden and risks
LT is generally well tolerated, and has proven to be safe and efficacious in
previous studies. However, the efficacy of LT in depressed patients with
comorbid T2DM has never been proven. In our opinion, taking together the burden
associated with participation (LT, actometery, study-diary, questionnaires,
fundus photography, venapunction, and optionally a euglycemic hyperinsulinemic
clamp procedure), and the low risks associated with the protocol, we believe
the potential group benefit outweighs the burden and risks associated with
participation. If proven efficacious, LT could be a valuable and affordable
non-pharmacological treatment option for patients with depression and comorbid
T2DM, improving both psychiatric and metabolic outcomes.
De Boelelaan 1118
Amsterdam 1081 HV
NL
De Boelelaan 1118
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects (pilot studie):
(1) Age 18-75 years
(2) Physically and psychiatrically healthy, as judged by an expert panel;Patients:
(1) Age 18 years or older
(2) Type 2 Diabetes Mellitus, as judged by an expert panel
(3) Depression (DSM-IV)
Exclusion criteria
Healthy subjects (pilot studie):
(1) A recent history of a serious medical event, as judged by an expert panel
(2) Hypersensitivity to drugs used
(3) Pregnancy
(4) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
(5) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family;Patients:
(1) Recent history (<2 months ago) of, or current light therapy
(2) Type 1 Diabetes Mellitus
(3) Recent history of a serious medical event or a serious medical condition, as judged by an expert panel
(4) Current use of oral glucocorticoids, melatonin, or cytostatics
(5) Recent change in antidepressant (<1 months ago) or blood-glucose lowering (<1 months ago) medication
(6) Psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, and severe acute suicidality, as judged by an expert panel
(7) Visual Acuity <60%, severe non-proliferative or preproliferative retinopathy, photocoagulated retinopathy, proliferative retinopathy (EURODIAB grades 3,4, and 5), recent history (<6 months ago) of relevant eye surgery, relevant eye surgery scheduled in the near future, senile macula degeneration
(8) A history of light-induced migraine or epilepsy, or severe side effects to light therapy in the past
(9) Hypersensitivity to drugs used
(10) Pregnancy
(11) Shift workers
(12) Poor commandment of the Dutch language or any (mental) disorder that precludes full understanding the purpose, instruction and hence participation in the study
(13) Individuals who have previously completed or withdrawn from the experimental phase of this study
(14) Individuals who are investigator site personnel directly affiliated with the study, or are immediate family
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45295.029.13 |
| OMON | NL-OMON25152 |